Chronic Kidney Failure Clinical Trial
Official title:
Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.
The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.
In parallel to the new hemodialyzer, Evodia blood lines were developed to improve
characteristics of the extracorporeal circuit in term of reduced activation of the
coagulation system and lower deposits of clot components.
The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low
thrombogenicity and that can be used with low heparin dose in order to reduce the patients'
bleeding risk at the end of HD treatment.
Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the
coagulation, will be performed during the study in order to evaluate the thrombogenicity of
the system.
The ionic clearance will be collected during all treatments to evaluate the performance of
the hemodialyzer.
The study will be divided into three steps
- Period 1: Usual heparin dose with usual hemodialyzer and standard blood lines
(baseline),
- Period 2: Decrease of heparin dose with Evodial hemodialyzer and standard bloodlines
- Period 3: Lowest heparin dose defined in step 2 using the system Evodial hemodialyzer
and SMA bloodlines.
Each patient included into the study will perform the three steps. As the risk of
extracorporeal circuit clotting will be rather important, no control group (usual
hemodialyzer with heparin decrease dose) will be performed.
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